Senior Vice President, Regulatory Affairs (NU21-287)

Catalyst is seeking an accomplished Senior Vice President, Regulatory Affairs to serve as a member of the senior management team reporting to the Company’s President & Chief Executive Officer. The successful candidate will work closely with the CEO, the Board and other members of the SMT to develop and advance Catalyst’s regulatory vision. The SVP, RA will have responsibility for driving the regulatory strategy that helps advance the clinical development of Catalyst’s pipeline programs and will be an important external “face” representing the Company with global regulatory agencies.

About Catalyst Biosciences, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.

Responsibilities

  • Develop global regulatory strategy for marketing applications.
  • Lead the development of regulatory submissions for FDA, EMA and other international agencies.
  • Directly manage a small, growing team within the Regulatory Affairs function to ensure Company’s compliance with applicable internal standards, FDA and other regulations, and associated requirements for pharmaceutical development.
  • Pro-actively drive communications with all regulatory bodies to obtain all necessary IND’s and other regulatory pre-approvals for clinical research, as well as BLA/MAA approvals for Company products on a timely basis.
  • Oversee the required regulatory processes for studying investigational drugs.
  • Serve as the primary liaison to US and international regulatory authorities for site inspections, presentations, submissions, and compliance matters.
  • Guide the establishment of procedures and processes that ensure document compliance with Regulatory Company guidance/template specifications and data standards.
  • Establish, develop and implement a pharmacovigilance system to ensure the clinical quality, efficacy and safety of all Catalyst products.
  • Oversee Regulatory Affairs product files to support compliance with all regulatory requirements.

**Title/Level to commensurate with educational and professional experience.

Requirements

  • BS degree in any of the physical and life sciences required. Advanced degree and/or professional certification preferred.
  • 15+ years in the pharmaceutical industry with direct regulatory experience in submissions and FDA interactions for new drugs (must include large molecules, including INDs, BLAs).
  • Biologics expert with knowledge of current FDA and EMA laws, rules and relevant guidance documents specifically relating to biologics.
  • Previous Orphan Drug experience required.
  • Global experience with prior success interacting with US and EU regulatory authorities required; previous experience dealing with Blood Products Advisory Committee would be ideal.
  • Accomplished leader and manager, ideally having effectively scaled an organization appropriately over time.
  • Extensive knowledge of U.S. and International regulations including cGMP, GCP, GLP, ICH guidance documents.
  • Experience managing consultants and contractors and ensuring the integrity and timeliness of their work.
  • Extensive knowledge and experience with eCTD regulatory filings/ FDA electronic submissions.
  • Strong understanding of Drug Development R&D, manufacturing, laboratory, and Quality Systems.
  • Previous participation in package insert negotiations.
  • Specific blood product experience, hemophilia and hemostasis therapies and experience with a subcutaneously administered agent, considered a plus.

Personal characteristics and culture fit

  • Executive presence, with excellent written, verbal and interpersonal skills to interact effectively internally with the Senior Leadership team and Board of Directors and externally with regulatory agencies.
  • Dynamic, strategic leader who will thrive in an entrepreneurial, fast-paced business environment.
  • Team player with ability to drive breakthrough results with passion, confidence, tenacity, and personal responsibility.
  • Motivated person of vision, integrity, energy, collegiality, and leadership.
  • Strong personal character coupled with a broad regulatory and scientific acumen, organizational skills and intellect.
  • Entrepreneurial spirit and commitment to collaboratively working “hands on” as needed to achieve corporate objectives.

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (NU21-287) in the subject line.

Head of Quality (XX21-289)

Catalyst Biosciences is seeking an accomplished individual to serve as the Head of Quality. The successful candidate will be a proven leader who will work closely with the company’s leadership team and company staff to develop and advance Catalyst Biosciences’ pipeline programs consistent with the company’s vision and in a manner compliant to quality regulations. 

The Head of Quality is a hands-on position responsible for driving the company’s quality function with a focus on Quality Systems and Quality Operations. This person will interact with internal departments to build and direct the corporation’s quality initiatives. In addition, this person will ensure adherence to quality standards for CMC activities performed at external contract manufacturing organizations and represent the company’s quality function during interactions with health authorities. 

About Catalyst Biosciences, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development. 

Responsibilities

  • Accountable for developing, articulating, and gaining alignment across the organization on the necessary internal quality policies, processes, and procedures that support advancement of the company’s pipeline in a manner compliant with governing regulations. 
  • Lead and direct the overall activities required to ensure key quality systems are developed and implemented, including a document control system/process, GxP training, and CAPA system. 
  • In the context of an outsourcing model, oversee a regulatory compliant quality operations function for the company, including CMC change control, review/acceptance of product production and release testing records, product disposition, and setting of product retest/expiry dating. • Collaborate/support clinical-regulatory compliance activities. 
  • Actively collaborate with development teams and functional areas to ensure quality standards are met. 
  • Ensures product manufacture, testing, and disposition are compliant to documentation filed with regulatory authorities. 
  • Direct the activities of subordinates to establish and maintain a high level of excellence regarding adherence to quality standards and scientific integrity. 
  • Coordinate with internal functional areas and external contract manufacturing organizations to represent the company during interactions with health authorities on quality matters. 
  • Develop and implement a process for presentation of periodic quality status reports to the company’s leadership team. 
  • Lead, manage, and ensure a state of inspection readiness on CMC matters. 
  • Proactively provide strategic input on development/commercialization efforts from a quality point of view. 
  • Leads the Quality Risk Management activities related to CMC. 
  • Actively support the company’s cultural initiatives. 

**Title/Level will commensurate with years of experience and education.

Requirements

  • Minimum of 10 years of quality experience in biotechnology with an emphasis on an outsourcing model. 
  • BS degree in Chemistry, Pharmaceutical Science, Microbiology, or related scientific field preferred. 
  • Comprehensive understanding of cGMP and quality systems applicable to pharmaceutical development and commercialization. 
  • Proven track record in building and managing a high performing quality team. 
  • Must be a dynamic leader with outstanding communication skills and an ability to effectively direct subordinates. 
  • Demonstrated strengths in problem solving, strategic planning, and working collaboratively. 

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (XX21-289) in the subject line.

Senior Manager, Clinical Quality Assurance (XX21-290)

Catalyst Biosciences is seeking an accomplished individual for the role of Senior Manager, Clinical Quality Assurance. The successful candidate will be a proven leader who will work closely with the company’s leadership team and staff to advance Catalyst Biosciences’ pipeline programs consistent with the company’s vision and in a manner compliant to Good Clinical Practice (GCP) / Good Laboratory Practice (GLP) regulations and guidance.

About Catalyst Biosciences, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.

Responsibilities

  • Key contributor to developing, implementing, and managing an integrated Clinical Quality Assurance program in the context of an outsourced development model.
  • Develop and oversee Clinical Quality Assurance Plans, including auditing of clinical trial sites and contract research organizations, and the collection and reporting of clinical trial data.
  • Ensure external GCP/GLP vendors are appropriately qualified and remain in an acceptable state of GCP compliance.
  • Contribute to the development and deployment of GCP/GLP associated standard operating procedures, processes, and quality standards.
  • Interface with relevant stakeholders to provide GCP/GLP compliance advice and expertise.
  • Manage an internal Clinical Quality Assurance non-conformance and CAPA program, including developing root cause analysis and ensuring timely closure of action items.
  • Provide guidance for key clinical systems, such as TMFs and document management.
  • Monitor current and projected clinical quality issues and contribute to continuous improvements in GCP/GLP compliance.
  • Organize and train internal staff on inspection readiness for GCP audits and support inspections by health authorities.
  • Actively support the company’s cultural initiatives.

**Title/Level to commensurate with educational and professional experience.

Requirements

  • Minimum of 5 years of Clinical Quality Assurance experience in pharmaceutical and biotechnology.
  • Experience in leading/managing audits of clinical vendors for regulatory requirements, ICH GCP, and industry standards/best practices.
  • Experience in leading audits of clinical/medical, bioanalytical, and genetic testing laboratories preferred.
  • RN or BS/BA degree in Life Sciences preferred.
  • Comprehensive understanding of GCP/GLP regulations and guidance.
  • Must have outstanding communication skills and an ability to effectively direct subordinates.
  • Demonstrated strengths in problem solving, strategic planning, and working collaboratively.

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (XX21-290) in the subject line.

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